Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-26
Brief Title:
NoNO-42 Trial in Acute Ischemic Stroke Patients Selected for Thrombolysis With or Without Endovascular Thrombectomy
Sponsor:
NoNO Inc
Organization:
NoNO Inc
Study Overview
Official Title:
A Multicentre Prospective Randomized Open Label Blinded-Endpoint Placebo-controlled Single-dose Trial to Determine the Efficacy and Safety of NoNO-42 in Participants With Acute Ischemic Stroke Selected for Thrombolysis With or Without Endovascular Thrombectomy ACT-42 Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ACT-42 is a domain of the ACT-GLOBAL platform NCT06352632
This trial is a Phase 2b multicenter prospective randomized open label blinded-endpoint PROBE controlled single-dose adaptive trial
A total of up to 600 male and female participants aged 45 to 90 years harboring an acute ischemic stroke who are eligible for an intravenous thrombolytic with or without endovascular thrombectomy therapy will be enrolled within 3 hours of stroke onsetlast known well
This trial is a Phase 2b multicenter prospective randomized open label blinded-endpoint PROBE controlled single-dose adaptive trial
A total of up to 600 male and female participants aged 45 to 90 years harboring an acute ischemic stroke who are eligible for an intravenous thrombolytic with or without endovascular thrombectomy therapy will be enrolled within 3 hours of stroke onsetlast known well
Detailed Description:
Because AIS is a medical emergency the trial is designed to enable the administration of standard-of-care treatments in order to save the life of the person concerned restore good health and alleviate suffering
A total of up to 600 male and female participants aged 45 to 90 years harboring an acute ischemic stroke who are eligible for an intravenous thrombolytic with or without endovascular thrombectomy therapy will be enrolled within 3 hours of stroke onsetlast known well Randomization will be 11 drugplacebo Randomization will be stratified by large vessel occlusion LVO yesno and a minimization algorithm to minimize the contribution of imbalances in baseline factors age sex baseline NIHSS score The design is adaptive with prospective rules for adaptive enrichment in which enrollment may be restricted to participants without an LVO LVO is defined as an occlusion of the intracranial ICA M1 or proximal M2
Randomized participants will be given a single 26 mgkg 20-minute intravenous dose of NoNO-42 or placebo placebo comprising normal saline infusion only with a target start time of less than 10 minutes from randomization
All participants will be followed for 90 days or until death if prior to 90 days for efficacy and 30 days for safety The end of the trial is defined as the date that all participants have completed their Day 90 contact
A total of up to 600 male and female participants aged 45 to 90 years harboring an acute ischemic stroke who are eligible for an intravenous thrombolytic with or without endovascular thrombectomy therapy will be enrolled within 3 hours of stroke onsetlast known well Randomization will be 11 drugplacebo Randomization will be stratified by large vessel occlusion LVO yesno and a minimization algorithm to minimize the contribution of imbalances in baseline factors age sex baseline NIHSS score The design is adaptive with prospective rules for adaptive enrichment in which enrollment may be restricted to participants without an LVO LVO is defined as an occlusion of the intracranial ICA M1 or proximal M2
Randomized participants will be given a single 26 mgkg 20-minute intravenous dose of NoNO-42 or placebo placebo comprising normal saline infusion only with a target start time of less than 10 minutes from randomization
All participants will be followed for 90 days or until death if prior to 90 days for efficacy and 30 days for safety The end of the trial is defined as the date that all participants have completed their Day 90 contact
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None